The Immunologic Effects of Dupilumab in the Treatment of Dermal Hypersensitivity Reaction

Inclusion Criteria:

• Established diagnosis of chronic idiopathic DHR as defined by presence of clinicaland histopathologic features of DHR for at least 6 weeks without an underlying causeor associated trigger

• Moderate-to-severe DHR as defined by greater or equal 5% total body-surface-area (TBSA) involvement and IGA of greater or equal to 3.

• Female subjects of childbearing potential (i.e., fertile, following menarche anduntil becoming post-menopausal unless permanently sterile) must agree either tocommit to true abstinence throughout the study and for 12 weeks after the last studydrug injection, when this is in line with the preferred and usual lifestyle of thesubject, or to use an adequate and approved method of contraception throughout thestudy and for 12 weeks after the last study drug injection.

• Subject willing and able to comply with all of the time commitments and proceduralrequirements of the clinical study protocol.

Exclusion Criteria:

• Subjects meeting 1 or more of the following criteria at screening or baseline:

• Had an exacerbation of asthma requiring hospitalization in the preceding 12 months.

• Reporting asthma that has not been well-controlled (ie, symptoms occurring on >2days per week, nighttime awakenings 2 or more times per week, or some interferencewith normal activities) during the preceding 3 months.

• Subjects with a current medical history of chronic obstructive pulmonary diseaseand/or chronic bronchitis.

• Cutaneous infection within 1 week before the baseline visit, any infection requiringtreatment with oral or parenteral antibiotics, antivirals, antiparasitics, orantifungals within 2 weeks before the baseline visit.

• Confirmed or suspected COVID-19 infection within 4 weeks before the screening orbaseline visit.

• Previous treatment with dupilumab.

• Pregnant women (positive urine pregnancy test result at the screening visit or thebaseline visit), breastfeeding women, or women planning a pregnancy during theclinical study.

• History of, current, or suspected lymphoproliferative disease or malignancy of anyorgan system within the last 5 years, except for basal cell carcinoma, squamous cellcarcinoma in situ (Bowen's disease), or carcinomas in situ of the cervix that havebeen treated and have no evidence of recurrence in the last 12 weeks before thebaseline visit.

• History of hypersensitivity (including anaphylaxis) to an immunoglobulin product (plasma-derived or recombinant, i.e., monoclonal antibody) or to lidocaine.

• Known active or latent tuberculosis (TB) infection.

• Known or suspected immunosuppression or unusually frequent, recurrent, severe, orprolonged infections as per investigator judgment.

• History of or current confounding skin condition (i.e., active atopic dermatitis,chronic urticaria, psoriasis, cutaneous T-cell lymphoma [mycosis fungoides or Sezarysyndrome], contact dermatitis, chronic actinic dermatitis, dermatitisherpetiformis).

• Planned or expected major surgical procedure during the clinical study.

• Currently participating or participated in any other study of a drug or device,within the past 8 weeks before the screening visit, or is in an exclusion period (ifverifiable) from a previous study.

• History of alcohol or substance abuse within 6 months of the screening.

• History of poor wound healing or keloid formation.